SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
FDA Recall Z-0794-2013 · Posted 2013-02-07
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Recalling FirmAllergen Medical
Recall StatusTerminated
Product CodeFTL
Date Initiated2013-01-08
Date Terminated2013-07-29
Product Quantity225 units (US) and 81 (Outside US)
Reason for Recall
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
Firm Action
Allergan sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 8, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers are requested to quarantine and return any unused devices in inventory . In addition, customers are asked to complete and return the acknowledgement form. Customers with questions should contact Allergan at 781-658-2800, Mon- Fri, 9 a.m. to 5 p.m. EST.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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